The Efficacy and Safety of Hyeonggaeyeongyo-tang for Chronic Rhinitis According to Pattern Identification in Korean Medicine

Overview

The purpose of this study is to evaluate the safety and effectiveness of Hyeonggaeyeongyo-Tang for chronic rhinitis according to pattern identification in Korean medicine.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2016

Interventions

  • Drug: Hyeonggaeyeongyo-tang

Arms, Groups and Cohorts

  • Experimental: Hyeonggaeyeongyo-tang

Clinical Trial Outcome Measures

Primary Measures

  • Change from baseline in ‘Total nasal symptom score (TNSS)’
    • Time Frame: At baseline, Day 2(Scheduled within a week of baseline), Week 3, 5, 9, 13
  • Change from baseline in ‘pre KiFDA-AR ver 2.0’ Questionnaire
    • Time Frame: At baseline, Day 2(Scheduled within a week of baseline), Week 3, 5, 9, 13

Secondary Measures

  • Pattern Diagnosis by ‘Cold-heat Pattern Identification Questionnaire’
    • Time Frame: Day 2(Scheduled within a week of baseline)
    • Pattern Diagnosis(either cold or heat pattern) based on the results of Cold-heat Pattern Identification Questionnaire
  • Change from baseline in ‘Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)’
    • Time Frame: At baseline, Day 2(Scheduled within a week of baseline), Week 3, 5, 9, 13
  • Pattern diagnosis by doctor of Korean medicine by traditional Korean medicine doctor’s four examination
    • Time Frame: Day 2(Scheduled within a week of baseline)
    • Pattern Diagnosis(either wind-heat or wind-cold pattern) based on the results of traditional Korean medicine doctor’s four examination(questioning/history taking, inspection, auscultation (listening) & olfaction (smelling), and palpation)
  • Diagnosis of secondary complications of chronic rhinitis (allergic rhinitis) by skin prick test
    • Time Frame: Day 2(Scheduled within a week of baseline)
    • Observed the allergic reaction for assessing the allergenicity of patients with allergic rhinitis
  • Change from baseline in total immunoglobulin E (IgE)
    • Time Frame: Day 2(Scheduled within a week of baseline), Week 5
  • Change from baseline in ‘Heart Rate Variability’
    • Time Frame: Day 2(Scheduled within a week of baseline), Week 5
  • Change from Baseline in ‘Ryodoraku values’
    • Time Frame: Day 2(Scheduled within a week of baseline), Week 5
    • Investigate the different changes on autonomic nervous system from Ryodoraku value. The 12 measured Ryodoraku points are 6 on the hand(represented as H) and 6 on the feet(represented as F).
  • Diagnosis of secondary complications of chronic rhinitis (allergic rhinitis and rhino-sinusitis) by Waters, Caldwell, and lateral view (paranasal sinus 3P)
    • Time Frame: Day 2(Scheduled within a week of baseline)
  • Change from baseline in ‘Perceived Stress Scale’
    • Time Frame: Day 2(Scheduled within a week of baseline), Week 5
  • Change from baseline in eosinophil count level
    • Time Frame: Day 2(Scheduled within a week of baseline), Week 5

Participating in This Clinical Trial

Inclusion Criteria

1. Patients who are diagnosed by moderate level of chronic rhinitis for more than 8 weeks

  • At least one of the following conditions: Nasal congestion, rhinorrhea, sneeze, pruritus – At least one of the following Moderate abnormality conditions: sleep disturbance; daily activity, physical exercise, leisure activity limitations; work/school work limitations; discomfort with several symptoms 2. Age between 19 and 65 years 3. Able to dialogue 4. Agree with informed consent Exclusion Criteria:

1. Patients who are taken one of the following drugs for treating rhinitis or acute upper respiratory infections etc

  • Drugs which determined to have negative effect on symptoms of rhinitis or skin prick test (oral or nasal) – Short acting anti-histamines / H1 blockers (drug use within lase 1 week) – Long acting anti-histamines / H1 blockers (drug use within lase 2 week) – Corticosteroids (drug use within lase 1 month) ④ Anti-cholinergic drug (drug use within lase 1 week) – Anti-leukotriene drug (drug use within lase 1 week) – Decongestants (drug use within lase 1 week) ⑦ Tricyclic antidepressants, phenothiazines (drug use within lase 2 week) ⑧ Non-steroidal analgesics (drug use within lase 1 week) ⑨ Drugs that is judged to be inappropriate for the trial by the researchers 2. Used Korean medicine for treating rhinitis within last 7 days 3. Patients who has severe disease, such as malignant tumor, severe dyslipidemia, liver or kidney dysfunction, anemia, active pulmonary tuberculosis, infection or systemic disease etc 4. Presence of internal nasal obstruction or nasal deformities or history of nasal surgery within 2 months 5. History of active respiratory disease(ex. asthma) 6. Hypertension or Diabetes 7. Experienced immunotherapy or systemic steroid treatments within last 3 months 8. Experienced drug allergic reactions 9. Experienced anaphylactic reactions, during allergen test 10. Female patients who are pregnant or lactating or have the chances of pregnancy 11. Patients who are participated other clinical trials within last 1 month 12. Patients who are unable to participate the trial (paralysis, severe mental or psychological illness, dementia, drug addiction, unable to make to participate in the trial, severe visual or auditory dysfunction, unable to visit hospital regularly, unable to communicate through spoken or written Korean etc) 13. Patients who are judged to be inappropriate for the clinical study by the researchers

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Kyung Hee University Hospital at Gangdong
  • Provider of Information About this Clinical Study
    • Principal Investigator: Minhee Kim, KMD – Kyung Hee University Hospital at Gangdong
  • Overall Official(s)
    • Seong-Kyu Ko, KMD, PhD, Study Chair, Kyunghee University

Citations Reporting on Results

Kim MH, Son J, Nam HJ, Ko SG, Choi I. Hyeonggaeyeongyo-Tang for Treatment of Allergic and Nonallergic Rhinitis: A Prospective, Nonrandomized, Pre-Post Study. Evid Based Complement Alternat Med. 2016;2016:9202675. doi: 10.1155/2016/9202675. Epub 2016 Sep 6.

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